Dengue Serostatus Study in the Philippines

Dengue Clinical Trial

Official title:

Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03465254
• Other study ID #: UPM REB 2016-435-01
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: June 2023

Study information

• Verified date: May 2023
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.

Description:

This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with <5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2996
• Est. completion date: June 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion criteria:

• Provide signed informed consent and assent (as applicable)

• Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization

• Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017

Exclusion criteria:

• Any subject whose parent/guardian refuse to provide informed consent and/or assent

• Children who do not belong to the specified age groups and not residents of the targeted communities

• Children <9 years old

• Children with history of bleeding disorder

• Any subject previously enrolled in a dengue vaccine clinical trial

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Severe Dengue
• Virologically-confirmed Dengue

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
University of the Philippines	Department of Health, Philippines, International Vaccine Institute, La Jolla Institute for Allergy & Immunology, Research Institute for Tropical Medicine, Philippines, University of North Carolina, World Health Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virologically-confirmed dengue (VCD)	The primary outcome measure is virologically confirmed dengue by RT-PCR	5 years